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临床试验/NCT06924528
NCT06924528已完成不适用

The Effects Of Toy In Chıldren Durıng Inhaler Therapy

Bakirkoy Dr. Sadi Konuk Research and Training Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年11月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
children's anxiety meter state

研究概览

简要总结

The purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. The purpose of this intervention is to reduce the child's anxiety and increase their emotional adjustment by improving adherence to the treatment.

详细描述

Respiratory diseases are commonly seen during childhood. Today, inhaler medication is frequently used in the treatment of lower respiratory tract diseases. Inhalation therapy is the process of delivering liquid medication in aerosol form directly to the respiratory tract and lungs using devices called nebulizers. Compared to other treatment methods, the direct delivery of medication to the lungs, the rapid onset of effect, and fewer systemic side effects make inhalation therapy the preferred method for treating children. In treatments administered through inhalation, if the inhalation is being applied for the first time, the child may experience fear and anxiety due to not knowing the procedure. After the nurse explains how the procedure is done, they should use distraction techniques to relax the child and support the effective continuation of the inhalation treatment. Distraction techniques are simple and inexpensive methods, and studies have proven their positive effect on children. This study is designed to investigate the effect of using a toy during inhaler treatment on children's anxiety and emotional state.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Seventy-two participants included in the study were divided into two groups: intervention and control. The assignment of participants to the intervention and control groups was done randomly by someone not involved in the study.

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The child being between the ages of 4 and 6,
  • The child being scheduled to receive their first inhaler treatment after admission to the unit,
  • No IV or IM interventions being performed before the inhaler treatment,
  • The child and parents being willing to participate in the study,
  • No mental or neurological disabilities present in the child or parent,
  • The child not having any life-threatening illnesses,
  • The child having an oxygen saturation of 95% or higher,
  • The child's body temperature not exceeding 37.5 degrees Celsius,
  • The child's cognitive level and motor development being appropriate for their age,
  • The child being able to count up to 10,
  • The parent being literate,
  • No visual or auditory problems present in the child or parent

排除标准

  • The child's general condition (tachycardia, fever, vomiting, etc.) and orientation (disorientation, lethargy, etc.) significantly deteriorating after the inhaler treatment begins,
  • The parent or child wanting to withdraw from the study at any stage of the research.

结局指标

主要结局

children's anxiety meter state

时间窗: five months

To measure state anxiety, children are asked to mark how they feel "right now." To measure trait anxiety, another copy of the scale is presented, and they are asked to mark how they "usually feel at home." Examples of being at home are provided to the children, like "think about when you were playing outside with a friend" and "think about sitting quietly watching TV." Before completing the scale, children were screened for their ability to rank order by size. They were asked to count to 10, and then answer, "Which is bigger, 7 or 4?" Children were also asked to identify the smallest of a series of four stacking cups. Children unable to complete these tasks successfully or who did not understand the instructions did not complete the scale.

次要结局

  • Children's Emotional Manifestation Scale(five months)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ayse Boke

Principal Investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (2)

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